Therapeutic Innovation & Regulatory Science

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Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency
Therapeutic Innovation & Regulatory Science - Tập 56 - Trang 753-764 - 2022
Jenn W. Sellers, Camelia M. Mihaescu, Kassa Ayalew, Phillip D. Kronstein, Bei Yu, Yang-Min Ning, Miguel Rodriguez, LaKisha Williams, Ni A. Khin
The United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) have collaborated in good clinical practice (GCP) inspections since September 2009. The two agencies operate under different regulatory frameworks for GCP oversight. No systematic assessments of GCP inspection findings have been reported. We identified common inspections of clinical investigators, sponsors, an...... hiện toàn bộ
Potential Future Drug Development Lag in Japan Based on an Analysis of Multiregional Clinical Trials in the US, Europe, and East Asia
Therapeutic Innovation & Regulatory Science - Tập 56 - Trang 523-529 - 2022
Atsushi Noguchi, Hideki Hanaoka, Yoshiaki Uyama
Although the “drug lag”—namely, the delay in drug approval time in Japan relative to the United States and/or European Union (US/EU)—has been shortened for drugs approved in Japan, there remain many new drugs that have been approved in the US/EU, but not in Japan. To assess the possibility of a future drug lag, this study has examined the current lag in drug development in Japan based on “Clinical...... hiện toàn bộ
New Benchmarks Characterizing Growth in Protocol Design Complexity
Therapeutic Innovation & Regulatory Science - Tập 52 - Trang 22-28 - 2018
Kenneth A. Getz, Rafael A. Campo
The Tufts Center for the Study of Drug Development and Medidata Solutions Inc analyzed data from 9737 protocols and 130,601 investigative site contracts associated with these protocols to derive updated benchmarks characterizing protocol complexity. The results of the study indicate that protocol design complexity continues to grow rapidly. Nearly all phase I, II, and III complexity measures assoc...... hiện toàn bộ
Costs of Quality in Clinical Development
Therapeutic Innovation & Regulatory Science - Tập 53 - Trang 706-713 - 2019
Bolennart Eriksson
The basis for this article is an individual project during a Master of Science program at Cranfield University, UK. Research and development (R&D) costs in the pharmaceutical industry have increased at a rate where costs have doubled compared to previous decades since the 1980s. In parallel, during recent years, there has been an increased focus on quality management within clinical development. F...... hiện toàn bộ
Optimal Sample Size for Use in Neonatal Pharmacokinetic Studies
Therapeutic Innovation & Regulatory Science - - 2022
Bo‐Hao Tang, Bu‐Fan Yao, John van den Anker, Wei Zhao
FDA Engages Collaborators to Address Nonclinical Data Challenges
Therapeutic Innovation & Regulatory Science - Tập 47 - Trang 41-45 - 2013
Timothy J. Kropp, Lilliam A. Rosario, Susan DeHaven, William Houser, Lou Ann Kramer, Shree Nath, Troy Smyrnios, Jeremy L. Wally
FDA and PhUSE cohosted a Computational Science Symposium (CSS) in 2012 that brought stakeholders from the pharmaceutical industry and government to work collaboratively to solve common needs and challenges. A nonclinical informatics workgroup was formed, dedicated to improving nonclinical assessments and regulatory science by identifying, collecting, and prioritizing key needs and challenges in th...... hiện toàn bộ
Improving the Standards of Reporting of Clinical Trial Data
Therapeutic Innovation & Regulatory Science - Tập 54 - Trang 717-722 - 2020
Jitendra Ganju
Although checklists and guidelines for reporting and interpretation of clinical trial results are of immense value there is still room for a biased presentation in journal publications. Two important sources of bias that remain are as follows: (1) The absence of a principle guiding the display of point estimates in abstracts. For example, bias arises, even for a primary endpoint, when the reported...... hiện toàn bộ
Survey of Safety Information in the Investigator’s Brochure: Inconsistencies and Recommendations
Therapeutic Innovation & Regulatory Science - Tập 52 - Trang 764-770 - 2018
Michael Jacob Klepper, Leander Fontaine
A survey was undertaken to gain an understanding of current industry practices in the preparation of the safety information for the Investigator’s Brochure (IB). Sixteen of a potential 25 respondents completed a survey (64% response rate). Five respondents represented pharmaceutical and biotech companies, and 11 were consultants or worked at contract research organizations for such companies. The ...... hiện toàn bộ
Adaptive Design Practice at the Center for Devices and Radiological Health (CDRH), January 2007 to May 2013
Therapeutic Innovation & Regulatory Science - Tập 50 - Trang 710-717 - 2016
Xiting Yang, Laura Thompson, Jianxiong Chu, Sherry Liu, Hong Lu, Jie Zhou, Shanti Gomatam, Rong Tang, Yu Zhao, Yunjiang Ge, Gerry W. Gray
Adaptive designs have generated great interest in the clinical trial community as a result of their versatility and efficiency. Recently, the Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA) surveyed all adaptive design applications submitted between 2007 and May 2013 for regulatory review. In this paper, we discuss the overall results and findings tha...... hiện toàn bộ
Wearable Technologies for Children with Chronic Illnesses: An Exploratory Approach
Therapeutic Innovation & Regulatory Science - Tập 55 Số 4 - Trang 799-806 - 2021
Flora McErlane, Elin Haf Davies, Cécile Ollivier, Anna Mayhew, Obuchinezia Anyanwu, Victoria Harbottle, Aimée Donald
Tổng số: 909   
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